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Suggested Citation:"8 Research Oversight." National Research Council and Institute of Medicine. 2005. Ethical Considerations for Research on Housing-Related Health Hazards Involving Children. Washington, DC: The National Academies Press. doi: 10.17226/11450.
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8
Research Oversight

A well-designed systems approach to research oversight that involves researchers, institutional review boards (IRBs), and funders best ensures that the ethics and science of human participants research are of high quality (Institute of Medicine, 2002). Many of the recommendations presented in previous chapters envision parallel roles for researchers and IRBs. In response to specific ethical issues raised by the context of housing health hazards research, the committee recommends that researchers consult with the affected communities (Chapter 5), ensure that parents’ decisions to enroll children in research is truly informed and voluntary (Chapter 6), and specify plans for addressing risks observed in the home, including risks that are not part of the research project (Chapter 7). In those chapters, we articulate complementary recommendations for IRBs, recognizing the IRBs’ role in reviewing, approving, and overseeing research; see Box 8-1.

Funders of research also play a significant role in establishing the requirements of the research they fund. Chapter 5 includes a recommendation that funders of housing health hazards research require and provide adequate funding for community involvement in such research. In addition, federal agencies that develop regulatory guidance play a significant role in developing guidance for IRBs and researchers on how regulatory requirements should be interpreted.

The general purpose of an IRB is to ensure that a research protocol that proposes to involve human participants protects the rights and welfare of human participants and complies with ethical standards and federal regulations. The effectiveness of IRB review and of the implementation by the

Suggested Citation:"8 Research Oversight." National Research Council and Institute of Medicine. 2005. Ethical Considerations for Research on Housing-Related Health Hazards Involving Children. Washington, DC: The National Academies Press. doi: 10.17226/11450.
×

BOX 8-1
Recommendations for IRBs from Other Chapters

Recommendation 5.2: Institutional review boards should require appropriate community involvement in housing health hazards research involving children and require that investigators’ protocols are responsive to any community concerns.

Recommendation 6.3: Institutional review boards that review intervention studies or longitudinal cohort studies on housing health hazards involving children should require that the informed consent process reflects appropriate community input and includes plans that ensure that parents of child participants understand the essential elements of the research.

Recommendation 7.4: Institutional review boards that review housing health hazards research should examine the researchers’ plans for responding to risks observed in the home and require that they be appropriate in the context of the research and the affected community.

U.S. Department of Health and Human Services (DHHS) of its regulations has been the subject of critical reports in recent years (Institute of Medicine, 2004). In response to those criticisms, DHHS in 2000 reorganized its oversight structure to emphasize the importance of protections for human research subjects: the entity charged with principal responsibility for human research subject protections was moved from an office in the National Institutes of Health (NIH) to the Office of Public Health and Science, which is in the office of the DHHS secretary (Institute of Medicine, 2004). This principal entity, now named the Office for Human Research Protections (OHRP, formerly the Office for Protection from Research Risks), is charged with overseeing compliance with DHHS regulations for the protection of human subjects. OHRP establishes criteria for and approves assurances of compliance with institutions engaged in DHHS-conducted or DHHS-funded human subject research, provides guidance on involving humans in research, develops and implements educational programs and resource materials, and promotes the development of approaches to enhance human subject protections.

OHRP is guided by the 11-member Secretary’s Advisory Committee on Human Research Protections (SACHRP). The advisory committee members are selected on the basis of their expertise in any of the several disciplines and fields pertinent to human subjects protection or clinical research. Membership of SACHRP also includes non voting ex-officio members who

Suggested Citation:"8 Research Oversight." National Research Council and Institute of Medicine. 2005. Ethical Considerations for Research on Housing-Related Health Hazards Involving Children. Washington, DC: The National Academies Press. doi: 10.17226/11450.
×

represent the Agency for Healthcare Research and Quality; the Centers for Disease Control and Prevention (CDC); the Food and Drug Administration; NIH; the Department of Housing and Urban Development (HUD); the Environmental Protection Agency (EPA); and any other ex-officio member the Secretary deems necessary. (Before 2002 the entity was known as the National Human Research Protection Advisory Committee).

SACHRP meets at least twice a year to discuss recommendations and advice to be provided to the secretary regarding ways to improve protections for human research participants. There are currently two active sub-committees, one focused on prisoners involved in research and one focused on children involved in research. The Subcommittee on Research Involving Children is currently evaluating the definitions and application of certain key regulatory terms under Subpart D, such as “minimal risk,” “minor increase over minimal risk,” “condition,” and “reasonably commensurate.” A key unresolved issue is “whether or not there is a…magnitude of harm above which normal children are routinely exposed to which we believe that they, like their disordered counterparts, should be exposed for the benefit of scientific [knowledge] on health problems affecting children” (Hawkins, 2004).

The rest of this chapter discusses issues specific to IRBs and funders that would further enhance the system of research oversight. In addition, it discusses in detail issues related to research that involves a minor increase over minimal risk and no prospect of direct benefit given the particular concerns regarding this type of research in the context of housing health hazards research.

RESEARCH PROTECTIONS

As discussed in Chapter 3, Subpart A of the federal regulations (45 CFR 46, the “Common Rule”) establishes the basic rules for the conduct of research; it also specifies the findings that an IRB must make in order to approve a research proposal (45 CFR 46.111). Subpart D of 45 CFR 46 provides a more substantive guide for research involving children, with protections balanced with the risk and benefits of a given design.

The primary funders of housing health hazards research involving children are HUD, CDC, NIH, and EPA. DHHS, which includes CDC and NIH, has adopted all the regulations in 45 CFR 46, including subpart D. HUD and EPA have adopted Subpart A, but they have not adopted Subpart D. As a result, there may be circumstances in which housing research involving children would not be required to comply with Subpart D, and the possibility of research placing children at risk without the oversight provisions is left open. While additional protections beyond those specified in the regulations are warranted, as discussed in this report, the federal

Suggested Citation:"8 Research Oversight." National Research Council and Institute of Medicine. 2005. Ethical Considerations for Research on Housing-Related Health Hazards Involving Children. Washington, DC: The National Academies Press. doi: 10.17226/11450.
×

regulations in Subpart D provide a useful framework for the conduct of all housing health hazards research involving children.

Guidance Regarding Interpretation of Subpart D

Subpart D specifies the types of research involving children that can be approved by an IRB. Provided other applicable criteria are met, projects may be approved if the research involves (1) no more than minimal risk, (2) greater than minimal risk but a prospect of direct benefit, or (3) a minor increase over minimal risk and no prospect of direct benefit but the potential to yield generalizable results about the participants’ disorder or condition. Projects that are not approvable under one of these categories may only be approved by the DHHS secretary, after review by a special national panel. Interpretation of the level of risk presented by specific interventions is inconsistent across IRBs (Shah et al., 2004; Institute of Medicine, 2004). For example, Shah et al. (2004) found that 23 percent of IRB chairs consider allergy skin testing minimal risk, 43 percent a minor increase over minimal risk, and 27 percent more than a minor increase over minimal risk. This variation is troublesome, because some IRBs may be allowing children to be subjected to inappropriate risks in research, while other IRBs may be rejecting valuable research whose risks are acceptable.

The categories of risk specified in Subpart D are crucial in determining the criteria under which a research project may be approved, but they are conceptually difficult to define. Shah et al. (2004) concluded that “IRB chairpersons need guidance on applying the federal risk and benefit categories” (p. 476). The difficulties are further complicated in the context of research on housing health hazards that is conducted in the participants’ homes because potential participants and community representatives may have a different view on what is minor or acceptable risk than do researchers or IRBs.

SACHRP is currently considering these terms and is expected to propose an updated list of interventions that may appropriately be considered minimal risk and minor increase over minimal risk, together with an explanation of the reasons for the decisions. The committee supports this ongoing work and believes it will provide the necessary foundation for OHRP to issue guidance that will help IRBs and researchers carefully consider what would justify labeling an intervention minimal risk or minor increase over minimal risk. In addition, a clearer understanding and agreement on minor increase over minimal risk, and greater consistency across IRBs, would help ensure that children in research are protected against risks that are unacceptable.

In the context of research that presents a minor increase over minimal risk and no prospect of direct benefit (Section 406), the federal regulations

Suggested Citation:"8 Research Oversight." National Research Council and Institute of Medicine. 2005. Ethical Considerations for Research on Housing-Related Health Hazards Involving Children. Washington, DC: The National Academies Press. doi: 10.17226/11450.
×

also specify that research must present experiences to child subjects that are reasonably commensurate with those “inherent” in their medical, psychological, or social situation. However, the regulations do not define “reasonably commensurate,” and there is no empirical information on what interventions are typically regarded as such by IRBs. Although the committee believes that skin testing is reasonably commensurate with having immunizations, a part of every child’s experience, IRBs differ in their views on what level of risk this poses (Shah et al., 2004). Similarly, the intervention must be “likely to yield generalizable knowledge about the subject’s disorder or condition which is of vital importance for the understanding or amelioration of the subjects’ disorder or condition.” Again, the regulations do not define “vital importance,” and there are no empirical data on how IRBs interpret the term. Finally, the regulations are not specific about whether healthy children with certain characteristics, including social or environmental characteristics (e.g., living in poor-quality housing) that place them at risk for adverse health outcomes, are intended to be included in this category of research (see below for discussion of this issue). Although decisions about whether a specific research protocol meets these criteria will still involve some value judgments on the part of IRBs, clarification on the intended meaning of these terms will help minimize differences across IRBs.

Additional guidance can be provided to clarify unusual circumstances. Guidance from federal oversight agencies or professional societies, such as public health and pediatric societies, can help clarify how to apply the regulations to atypical contexts. For example, an ethical argument can be developed for a specific decision with respect to seeking consent from individuals who are not the primary subjects of the research (see Chapter 7 for discussion of third parties). Without specific guidance, an IRB may find it difficult to decide which arguments to accept.

Guidance Regarding Economically and Educationally Disadvantaged Populations

Subpart A of the federal regulations reminds IRBs to “be particularly cognizant of the special problems of research involving vulnerable populations such as children, prisoners, pregnant women, mentally disabled persons, and economically and educationally disadvantaged populations” (45 CFR 46.111(a)(3)) and asks them to consider whether vulnerability calls for additional protections (45 CFR 46.111(b)). In the case of children, Subpart D articulates specific additional protections. Subparts B and C specify additional protections for pregnant women and prisoners, respectively. No similar regulatory guidelines, nor any guidance on how to interpret these provisions, have been issued in the case of economically and educationally disadvantaged populations, although some researchers have

Suggested Citation:"8 Research Oversight." National Research Council and Institute of Medicine. 2005. Ethical Considerations for Research on Housing-Related Health Hazards Involving Children. Washington, DC: The National Academies Press. doi: 10.17226/11450.
×

called for them (Stone, 2003). The broad directives in Subpart A regarding such disadvantaged populations provide little specific guidance and few specific requirements.

As stressed throughout this report, housing health hazards research raises unique issues related to targeting residents of poor-quality housing who are typically economically and educationally disadvantaged. While community involvement and enhanced efforts to facilitate informed consent as we recommend will address some of the issues raised in this research, specific guidance on how to design and conduct research with economically and educationally disadvantaged populations would benefit IRBs and researchers.

Special Considerations Regarding Section 406 Research

IRBs that review research that presents a minor increase over minimal risk and no prospect of direct benefit (Section 406) under Subpart D must assess whether the research is likely to generate generalizable knowledge about the targeted children’s “disorder or condition.” The intention of such research is to gain knowledge “of vital importance” about their disorder or condition with the goal of ultimately preventing or ameliorating it. In the biomedical fields, such studies might explore the pathophysiology of a childhood disease in order to develop better tests and therapies. For example, a research project might place an intravenous catheter into a child with diabetes to measure levels of blood sugar and hormones that regulate blood sugar levels, in order to understand how those levels are affected by such daily activities as exercise. Such studies might lead to recommended regimens for administering insulin that better control blood sugar. Although this would benefit future generations of children with diabetes, there is no direct benefit to the child subjects. Such research is permitted under Section 406 in order to advance treatment protocols and potentially improve the functional health of children with diabetes. Section 406 attempts to strike a balance between allowing research that could lead to improved health among children and not putting vulnerable children at greater than minimal risk without the prospect of direct, personal benefit.

Ethical Conduct of Clinical Research Involving Children (Institute of Medicine, 2004) grappled with definitional issues related to Section 406 research in the context of clinical research and offered the following recommendation:

In determining whether proposed research involving a minor increase over minimal risk and no direct benefit can be approved, the term condition should be interpreted as referring to a specific (or a set of specific) physical, psychological, neurodevelopmental, or social characteristic(s) that an

Suggested Citation:"8 Research Oversight." National Research Council and Institute of Medicine. 2005. Ethical Considerations for Research on Housing-Related Health Hazards Involving Children. Washington, DC: The National Academies Press. doi: 10.17226/11450.
×

established body of scientific evidence or clinical knowledge has shown to negatively affect children’s health and well-being or to increase their risk of developing a health problem in the future [emphasis added] (p. 130).

The report noted that a narrow definition of “disorder or condition” to refer only to an “illness, disease, injury, or defect” would discourage research with “children who are currently healthy but at risk of serious illnesses that could potentially be prevented or mitigated through early interventions” (p. 129). At the other extreme, a very broad interpretation of disorder or condition would include “almost any social, developmental, or other characteristic” and therefore “justify exposing a child to a higher level of research risk” (p. 129). The report also noted that it is important to “identify specific circumstances or conditions” that “contribute to children’s poor or good health” but cautioned that “children’s social, economic, racial, ethnic, and environmental characteristics or circumstances do not, in themselves, necessarily justify exposing a child to a higher level of risk in research that is not expected to benefit them directly” (pp. 129-130). It further required:

Investigators who define a research population on the basis of social characteristics or “conditions”—such as ethnicity, family circumstances, or economic status—must present a case that the condition has a negative impact on children’s health and well-being that is relevant to the research question (p. 130).

This committee agrees with the issues outlined in Ethical Conduct of Clinical Research Involving Children and its concerns about justice. We appreciate that “disorder or condition” must be interpreted to include healthy children at risk for a serious condition in order to carry out studies of the pathophysiology of diseases and to create the foundation of knowledge that allows therapeutic and preventive interventions or diagnostic tests to be developed.

However, for research on housing health hazards involving children, the ethical dilemmas are particularly pronounced given the context of the research—research that is often conducted with economically and educationally disadvantaged populations with multiple vulnerabilities. The primary factor that places them at risk is environmental: poor-quality housing because of the lack of decent affordable housing for children in low-income families. Thus, the health risk results not from a physical susceptibility to disease, but from environmental conditions that could be improved by better quality housing. At the same time, such populations potentially have the most to gain from such research because they bear an undue burden of poor health resulting from poor-quality housing.

Supporters of this research argue that it is needed to understand and ameliorate the health hazards in poor-quality housing that put children at

Suggested Citation:"8 Research Oversight." National Research Council and Institute of Medicine. 2005. Ethical Considerations for Research on Housing-Related Health Hazards Involving Children. Washington, DC: The National Academies Press. doi: 10.17226/11450.
×

risk. Such research might lead to better tests to identify children at risk for adverse health outcomes and to affordable interventions that effectively and safely mitigate the risks of poor-quality housing. Identification of such interventions is particularly important because it is unlikely that the stock and availability of good-quality, affordable housing will increase in the foreseeable future. To forgo such research might also forgo the opportunity to develop better approaches to ameliorating health disparities and improve the health outcomes of children in poor-quality housing: in trying to be sensitive to the potential for exploitation of poor and minority children, the opportunity to reduce the causes of their disadvantages may be lost. Advocates of research further argue that such research can be designed and implemented in a way that is sensitive to and does not exacerbate existing inequalities because, by definition, the physical risks of such procedures are no greater than a minor increase over minimal risk and are transient.

On the other side, there are also strong ethical concerns about allowing research to be carried out that presents more than minimal risk but does not offer the prospect of direct benefit. The committee is reluctant to allow children who are already vulnerable because of poor housing, poverty, and poor educational opportunities to be subjected as a group to greater risks in research than children from more privileged backgrounds. Moreover, it could be stigmatizing for children who already have multiple vulnerabilities if they are selected for such studies on the basis of poverty and living in poor housing, rather than on a more individualized determination of increased risk for disease and disability. Children from these environments are disproportionately from racial and ethnic groups that have suffered discrimination, and research may reinforce negative stereotypes. Finally, the committee is concerned that the long-term benefits of research might not accrue to the low-income populations who bear the burdens of research. For example, children with asthma from housing exposure to allergens who are from higher socioeconomic classes might be more likely to benefit from any clinical advances because they have better access to health care or the resources to implement environmental interventions.

The justification for a short-term risk to research participants is long-term improvements in health. However, the connection between well-intentioned research and improved health for disadvantaged populations may be tenuous. People who are poor and members of ethnic minorities in the United States have suffered discrimination in health care and experience ongoing health disparities (Institute of Medicine, 2003). They might question whether policy makers will actually implement the health and housing policies that research suggests would effectively ameliorate health disparities.

The committee struggled with these ethical dilemmas. Although the committee could not identify any specific housing health hazards research project that is or was conducted under Section 406, we did not want to

Suggested Citation:"8 Research Oversight." National Research Council and Institute of Medicine. 2005. Ethical Considerations for Research on Housing-Related Health Hazards Involving Children. Washington, DC: The National Academies Press. doi: 10.17226/11450.
×

close off potentially valuable research to ameliorate housing health hazards. At the same time, the committee is also deeply troubled by ethical concerns in putting vulnerable children at more risk than children from more privileged backgrounds. The committee considered strong arguments for allowing such research to proceed carefully and also strong arguments for protecting children who were already vulnerable in many ways.

The committee noted that the original recommendation by the National Commission that established this category of research did not address the definition of disorder or condition (including whether characteristics that place healthy children at risk for a negative health outcome or increase the risk of developing a health problem should be included), and that no specific guidance or regulations related to disorder or condition have been issued. However, the National Commission’s report also states that “It is necessary to learn more about normal development as well as disease states in order to develop methods of diagnosis, treatment and prevention of conditions that jeopardize the health of children, interfere with optimal development, or adversely affect well-being in later years” (National Commission, 1977, p. 11). This could be interpreted to suggest that the National Commission envisioned a wide latitude for the term “condition” and believed it encompassed all circumstances that jeopardize the health of children or adversely affect well-being in later years—including poverty and poor-quality housing. Others believe that that the overall language in the report suggests that this was not the National Commission’s intent.

Because of this ambiguity and the substantial potential controversy when this type of research involves economically and educationally disadvantaged populations, this committee concludes that the OHRP should clarify what constitutes a disorder or condition before research that defines disorder or condition based on social characteristics should be allowed to proceed. In developing such clarification, OHRP should articulate implementation considerations and ensure that there is the opportunity for significant public comment in addition to the public input received during the development of SACHRP’s recommendations (see above). A determination of whether guidance is sufficient or, alternatively, if additional regulations are warranted should be made part of this public process.

The several additional protections outlined in this report should be considered as part of the guidance. Specifically, the committee concluded that such research should require that the community is meaningfully consulted (Chapter 5) and that procedures are in place to ensure fully informed and voluntary consent (Chapter 6). Although Chapter 5 outlines a range of approaches to community involvement, the committee concludes that research involving more than minimal risk and no prospect of direct benefit

Suggested Citation:"8 Research Oversight." National Research Council and Institute of Medicine. 2005. Ethical Considerations for Research on Housing-Related Health Hazards Involving Children. Washington, DC: The National Academies Press. doi: 10.17226/11450.
×

that targets economically and educationally disadvantaged children heightens sensitivity to historical issues of injustice and distrust of research and warrants an intensive, ongoing approach to community involvement. Investigators should be required to engage in meaningful and ongoing dialogue in partnership with the community regarding the design of the project, including discussion of the research question, the risks of the research and the hazard being studied, the knowledge to be gained by the research, and the relevance and importance to the community. This approach will ensure that potentially controversial research with children with multiple vulnerabilities is vetted with the affected communities, carefully justified, and fully understood by the parents of child subjects.

The committee believes that if the definition of disorder or condition is determined to include a social characteristic or condition that is associated with poor health outcomes or an increased risk of developing a health problem, the review of these protocols would be strengthened if IRBs were more explicit and transparent about their reviews. Given the considerable public controversies surrounding some research protocols under Section 406, IRBs should be encouraged to state their reasoning explicitly and document it. An IRB should explain how it determined that all the criteria in Section 406 were met: that the research presents a minor increase over minimal risk, that the intervention presents experiences that are reasonably commensurate with the medical and psychosocial situations of the child subjects, that the knowledge gained from the research is of vital importance to understanding or ameliorating the participants’ disorder or condition, and that provisions for parental permission and children’s assent are adequate. Moreover, as the Institute of Medicine committee suggested: “Investigators who define a research population on the basis of social characteristics or ‘conditions’—such as ethnicity, family circumstances, or economic status—must present a case that the condition has a negative impact on children’s health and well-being that is relevant to the research question” (Institute of Medicine, 2004, p. 130). The process of community consultation will be helpful in this regard; the protocol and consent documents should be circulated to community representatives for their comments and suggestions. If researchers decide not to adopt major suggestions from the community consultation process and the IRB agrees, the IRB should communicate the reasons for its decision to the community representatives. This communication will allow the IRB to explain its reasoning to the community and also to hear the community’s response. The committee believes that significant disagreements are best resolved before a study begins and children are enrolled, rather than after it has begun. In addition, heightened monitoring by IRBs and, where appropriate, by data and safety monitoring boards of progress reports of research projects approved under Section 406 may be warranted. Careful monitoring would help ensure that children do not experience unwarranted risks.

Suggested Citation:"8 Research Oversight." National Research Council and Institute of Medicine. 2005. Ethical Considerations for Research on Housing-Related Health Hazards Involving Children. Washington, DC: The National Academies Press. doi: 10.17226/11450.
×

The guidance recommended above on research involving economically and educationally disadvantaged populations would assist IRBs in reviewing such protocols. Similarly, guidance on how to interpret minimal risk, and minor increase over minimal risk are essential since the decision about whether a given protocol represents minimal risk, a minor increase over minimal risk, or more than a minor increase over minimal risk emanates from the IRB.

If an IRB determines that a project is not approvable under Section 406 but is likely to generate knowledge of national significance, the protocol can also be considered for review under Section 407, which provides for the review of protocols by a special national panel, an opportunity for public comments on the protocol, and approval by the DHHS secretary. In the past, the 407 process was often prolonged, and few protocols have been reviewed and approved under this mechanism (Kopelman and Murphy, 2004). OHRP has improved the review process, eliminated the backlog of cases, and reduced the amount of time required for a decision. The greatest advantage of these special panels is the opportunity for public discussion of the merits of proposals and about “the level of research risk that should be permitted with minor subjects” and “how the values of scientific progress and the protection of the rights and welfare of subjects should be ranked when they conflict” (Kopelman and Murphy, 2004, p. 1788). Particularly for projects likely to generate substantial controversy, transparency in the review process will result in greater accountability and ultimately in greater public trust that the review has been impartial and fair. Furthermore, IRBs that review sensitive protocols, particularly protocols likely to generate substantial controversy, can request a review by OHRP of whether a project they are considering approving should instead undergo a special panel review under Section 407. OHRP can provide guidance on whether the proposed protocol is approvable under Section 404, 405, or 406, or if it requires review under 407.

INSTITUTIONAL REVIEW BOARDS

The Common Rule specifies requirements related to IRB functions and operations, including both the initial review of projects and their continuing review, as well as requirements for IRB membership (45 CFR 46.107; 21 CFR 56.107). IRBs are responsible for reviewing research protocols to ensure that they meet all of the regulatory requirements to protect human participants. In conducting their review, IRBs must make a series of determinations related to whether specific aspects of the protocol meet the requirements of the federal regulations (see Chapter 3). In the case of research involving minimal risk to participants, an IRB can provide an expedited review by less than the full committee (45 CFR 46.110).

Suggested Citation:"8 Research Oversight." National Research Council and Institute of Medicine. 2005. Ethical Considerations for Research on Housing-Related Health Hazards Involving Children. Washington, DC: The National Academies Press. doi: 10.17226/11450.
×

In their continuing review of ongoing research (see, e.g., 45 CFR 46.109), IRBs must pay particular attention to any unanticipated risks that emerge during the course of the research and meet several requirements. Continuing review must occur at least annually, with more frequent review required if the research protocol changes significantly or if the level of risk presented by the protocol warrants it. If, as a result of continuing review, the IRB determines that the research as conducted does not meet the requirements of the federal regulations and is not consistent with the IRB’s initial approval, or if it finds unexpected serious harm to participants in the research, the IRB may suspend or terminate its approval of the research. In such cases, the IRB must give the reasons for such action and promptly notify the investigator, “appropriate institutional officials, and the Department or Agency head” (45 CFR 46.113).

An IRB must have at least five members. At least one member must be concerned primarily with scientific topics, and at least one member must be concerned primarily with nonscientific topics. At least one must not be affiliated with the institution (that houses the IRB) directly or through a family member. These nonaffiliated and nonscientific members are expected to represent the concerns of research participants and the communities from which participants are drawn. Taken together, the members must have sufficient expertise, experience, and diversity of backgrounds to promote competent review of the usual kinds of research conducted by the institution and to promote “respect for its advice and counsel. Diversity of backgrounds includes not only areas of scientific or professional expertise but also culture, race, and gender” (Institute of Medicine, 2004, p. 97). IRBs also have ways to supplement their expertise. IRBs that regularly review proposals that include children are not required to have a member or members who have expertise and experience with children, but they are advised to consider the inclusion of such individuals. The regulations provide that IRBs may seek assistance from “individuals with competence in special areas…which require expertise beyond or in addition to that available on the IRB (45 CFR 46.109 (f)). OHRP guidance also strongly recommends that institutions provide appropriate education and training for investigators, IRB members, and others involved in research oversight.

The goals of research oversight are to safeguard research participants and to ensure that research is conducted in an ethical manner. Neither goal is well served if a review is either too permissive or too stringent because of unusual features of a specific research project. Several issues affect the ability of IRBs to provide effective oversight of housing health hazards research.

Suggested Citation:"8 Research Oversight." National Research Council and Institute of Medicine. 2005. Ethical Considerations for Research on Housing-Related Health Hazards Involving Children. Washington, DC: The National Academies Press. doi: 10.17226/11450.
×

IRB Expertise

The criteria for the approval of research and the elements of informed consent as set forth in Subpart A of the federal regulations are broadly applicable to a wide variety of research types. However, a specific type of research under review may differ from that usually conducted at a given institution and seen by its IRB. Moreover, the language of the regulations suggests that the authors had clinical trials in mind. For example, the consent requirement that research participants be told what alternatives they may be forgoing is worded in terms of “alternative procedures or courses of treatment” (45 CFR 46.116(a)(4) [emphasis added]). If a researcher proposing a hypothesis-generating ethnographic study comes before an IRB that is most familiar with drug trials and other hypothesis-testing research, the IRB members may have little basis for evaluating the risks and benefits. The social, behavioral, and economic sciences research community reports such concerns, with IRBs perceived as overestimating the risks presented by research in those fields and thereby obstructing worthwhile research (National Research Council, 2003). Thus, the research community has concerns that IRBs are not able to accurately assess the risks presented by protocols unfamiliar to them.

To determine whether risks have been minimized to the extent possible, consistent with sound research design, an IRB must understand the types of research it is reviewing. The IRB must include members (or consultants) who know what constitutes sound research design and who can judge whether less risky approaches than those proposed can be used without compromising the science at hand. Typically, an institution will recruit as its IRB(s) members who are themselves researchers and who have a basic familiarity with the sorts of research that frequently come under scrutiny. In the case of housing health hazards research, IRBs should consider the possibility of including local community residents who are representative of the community: for example, if the community is primarily a low-income minority community, the IRB representative should be as well. If the IRB reviews a significant amount of housing health hazards research, it should consider constituting a community advisory board.

Although there is no empirical evidence that IRBs do not have the necessary expertise to review housing health hazards research, several recent IOM reports have pointed to the need for IRBs to have expertise relevant to the type of projects being reviewed. Ethical Conduct of Clinical Research Involving Children (Institute of Medicine, 2004) emphasizes that IRBs that review research involving children need expertise in the “biological, medical, behavioral, and emotional dimensions” of research involving children and points out that IRBs have a variety of mechanisms available to ensure the necessary expertise, including using consultants or referring pro-

Suggested Citation:"8 Research Oversight." National Research Council and Institute of Medicine. 2005. Ethical Considerations for Research on Housing-Related Health Hazards Involving Children. Washington, DC: The National Academies Press. doi: 10.17226/11450.
×

tocols to other IRBs with the requisite expertise. Responsible Research (Institute of Medicine, 2003) suggests that “the goal of research organizations should be to assemble a board with at least 25 percent of its membership not affiliated with the institution, not trained as scientists, and able to represent the local community and/or the participant perspective” (p. 96). This suggestion mirrors a similar recommendation made by the National Bioethics Advisory Committee (2001). As discussed earlier in this report, issues of community representation are particularly salient in the context of housing health hazards research.

Although research on housing health hazards appears to be increasing, there are still relatively few institutions that conduct such research in comparison with other types of research, such as biomedical research. IRBs that do review such research should ensure that they have the necessary expertise to provide a thorough review. IRBs can increase their familiarity with any unique aspects of housing health hazards research when such studies begin to be presented for review and can expand their expertise as necessary.

The regulations recommend that when IRBs deal frequently with vulnerable participants, “consideration shall be given to the inclusion of one or more individuals who are knowledgeable about and experienced in working with” such persons and issues (45 CFR 46.107(a)). An IRB should have or develop the competence necessary to carry out the tasks set forth in the regulations. IRBs need to develop familiarity with housing health hazards research if they are to perform a good risk-benefit assessment, know what questions to pose to help (or challenge) an investigator, and be consistent in interpreting the regulations in this context. Federal regulations require that the IRB membership include people with the necessary expertise to “promote complete and adequate review of research activities commonly conducted by the institution” (45 CFR 46.107(a)). Although the regulations do not specifically require that the IRB membership include the expertise to review research not commonly conducted by the institution, there are other strategies an IRB can pursue to facilitate “complete and adequate review.”

Several models for improving IRB expertise are possible, with the appropriate choice being based on the volume of such research seen by a given IRB. If a center does a large amount of nonclinical research, it may be appropriate to have dedicated IRBs that specifically review projects involving housing health hazards research and develop the needed expertise. It will often be appropriate to include IRB members who have a good working knowledge of housing health hazards research.

If an institution becomes involved only occasionally in housing health hazards research or in nonclinical research more generally, it is unlikely that an IRB with sufficient expertise can be empaneled locally. In such cases, federal regulations specifically allow an IRB to engage a nonvoting consultant to assist in the review (45 CFR 46.107(f)). The regulations also

Suggested Citation:"8 Research Oversight." National Research Council and Institute of Medicine. 2005. Ethical Considerations for Research on Housing-Related Health Hazards Involving Children. Washington, DC: The National Academies Press. doi: 10.17226/11450.
×

provide opportunities for IRBs to conduct cooperative or collaborative reviews for projects that involve more than one institution (45 CFR 46.114). In the case of cooperative projects, IRBs may “enter into a joint review arrangement, rely upon the review of another qualified IRB, or make similar arrangements for avoiding duplication of effort.”

There are also other options available to obtain expertise in a consultative capacity. For example, central review boards can serve as consultants to local IRBs that lack the needed expertise. These could be central review boards not affiliated with an institution, or they could be the IRB of an institution at which such research is more common and where the needed expertise resides. In addition, central review boards can serve as the IRB of record in such circumstances: that is, a local IRB can delegate review of the protocol to a central review board with the requisite expertise.

If a specific competence or expertise is needed to thoroughly review a particular protocol, there may be both internal and external ways to meet this need, and the two may often be used well together. For example, if an institution and its IRB often review housing health hazards research, members of the target community or communities can be invited to serve as institutionally unaffiliated IRB members. If this unique role is taken seriously by the sponsoring institution and the IRB, it can enhance community representatives’ ability to influence the manner in which research is conducted.

Research on nonaffiliated and nonscientific members demonstrates that they believe their role is to represent the community of human participants, especially those considered vulnerable by race, age, or social class, in addition to giving feedback on the accessibility and appropriateness of consent documents (Sengupta and Lo, 2003). However, many feel intimidated in interactions with scientific members of the review boards and believe that more training and education would allow them to perform their roles more effectively. In addition, IRBs often have one token community member or a community resident affiliated with the institution. One resident cannot represent the diversity of an entire community and should not be viewed as doing so. In addition, community representation on an IRB should not in and of itself be considered adequate community involvement. As discussed in Chapter 5, researchers should be required to involve the affected community in the design and implementation of their studies.

If inviting a community member(s) to serve on the IRB is not feasible or is too limited (e.g., if the communities served are several and diverse), persons from the community of interest can be called on to serve as nonvoting consultants in the review process. Finally, if the structure exists or can be developed within the community under study, a community advisory board can be established to consult with the institution and its IRB on research oversight issues. To ensure that the IRB provides independent

Suggested Citation:"8 Research Oversight." National Research Council and Institute of Medicine. 2005. Ethical Considerations for Research on Housing-Related Health Hazards Involving Children. Washington, DC: The National Academies Press. doi: 10.17226/11450.
×

BOX 8-2
Possible Approaches to Ensuring Adequate IRB Review

  • Include institutionally affiliated IRB members with a good working knowledge of housing health hazards research

  • Involve community representatives as institutionally unaffiliated IRB members

  • Use a nonvoting IRB consultant with necessary expertise

  • Use community residents as IRB consultants

  • Establish a community advisory board to consult with the IRB

  • Delegate review to a central review board with requisite expertise

  • Conduct a collaborative review with another IRB (when more than one institution is involved)

  • Establish a dedicated IRB to review housing health hazards research

review, such a board should be distinct from any community advisory board(s) established by researchers (see Chapter 5).

The particular expertise needed will vary depending on the specific research protocol, and the appropriate IRB response will vary based on the frequency with which it is asked to review housing health hazards research and the nature of the research; see Box 8-2 for a summary list of possible approaches. Community perspectives might include expertise on cultural and language issues specific to the community. Another perspective that may be needed is environmental health.

IRB Submissions

IRBs should convey a clear expectation that ethical issues will be addressed in research protocols. Requiring structured information can help ensure that an IRB has adequate information to determine whether a given study is allowable under the federal regulations and has met the additional requirements articulated in this report. IRBs can also increase the likelihood that applications will include the detail and background necessary to understand how and why the research may meet the requirements for approval (Council for International Organizations of Medical Sciences, 2002). Institutions should strive to develop an oversight process that leads researchers to present their protocols to the IRB in a way that focuses on the pertinent regulatory and ethical issues.

One option would be development of targeted application forms for nonclinical research that asks for specific information and allows it to be

Suggested Citation:"8 Research Oversight." National Research Council and Institute of Medicine. 2005. Ethical Considerations for Research on Housing-Related Health Hazards Involving Children. Washington, DC: The National Academies Press. doi: 10.17226/11450.
×

provided in a format appropriate to the type of research. Currently, researchers are often expected to fit their study description into a form designed for a quite different type of research, such as a clinical trial. For example, for a study that will involve a minor increase over minimal risk without the prospect of direct benefit (see above), the application process and form could specifically solicit a description of the “condition” that might make the study eligible for approval under Section 406. In addition, the application could ask for information specific to the recommendations in this report; for example, it could include clear requirements for researchers to provide information on how they have consulted with the affected community and responded to the community’s needs, expectations, and concerns; how they have ensured that parents of child subjects understand the essential features of the research and relevant risks; and what plans they have developed for responding to risks observed in the home.

CONCLUSIONS AND RECOMMENDATIONS

The existing federal regulations under Subpart D provide a useful beginning framework for research involving children. However, the committee recommends additional safeguards to help ensure that housing health hazards research will meet careful ethical scrutiny. We believe that they will offer meaningful protections and ensure that vulnerable children are not subjected to unacceptable research risks, while allowing appropriate research aimed at ultimately ameliorating housing health hazards. At the same time, these recommendations will allow research of vital importance ultimately ameliorating housing health hazards to proceed without undue delay. The committee further concludes that the composition of an IRB is an important determinant in whether it has the necessary expertise to provide complete and adequate oversight of housing health hazards research.

Recommendation 8.1: All federal agencies—including the U.S. Department of Housing and Urban Development and the Environmental Protection Agency—private foundations, and other funders of research on housing health hazards involving children should at a minimum adopt the current regulatory framework in Subpart D of 45 CFR 46.

Recommendation 8.2: The Office of Human Research Protections should issue guidance to institutional review boards on how to interpret the key regulatory terms—“minimal risk,” “minor increase over minimal risk,” “disorder or condition,” “reasonably commensurate with those inherent in their actual or expected medical, dental, psychological, social, or educational situations,” and “vital importance”—in the context of housing health hazard research.

Suggested Citation:"8 Research Oversight." National Research Council and Institute of Medicine. 2005. Ethical Considerations for Research on Housing-Related Health Hazards Involving Children. Washington, DC: The National Academies Press. doi: 10.17226/11450.
×

Recommendation 8.3: The Secretary’s Advisory Committee on Human Research Protections should develop guidelines for research with economically and educationally disadvantaged participants for use by the Office for Human Research Protections in issuing guidance for researchers and institutional review boards.

Recommendation 8.4: Institutional review boards that review housing health hazards research involving children should ensure that those boards have the necessary expertise to conduct a complete and adequate review, including expertise on research involving children and community perspectives.

Suggested Citation:"8 Research Oversight." National Research Council and Institute of Medicine. 2005. Ethical Considerations for Research on Housing-Related Health Hazards Involving Children. Washington, DC: The National Academies Press. doi: 10.17226/11450.
×
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Ethical Considerations for Research on Housing-Related Health Hazards Involving Children explores the ethical issues posed when conducting research designed to identify, understand, or ameliorate housing-related health hazards among children. Such research involves children as subjects and is conducted in the home and in communities. It is often conducted with children in low-income families given the disproportionate prevalence of housing-related conditions such as lead poisoning, asthma, and fatal injuries among these children. This book emphasizes five key elements to address the particular ethical concerns raised by these characteristics: involving the affected community in the research and responding to their concerns; ensuring that parents understand the essential elements of the research; adopting uniform federal guidelines for such research by all sponsors (Subpart D of 45 CFR 46); providing guidance on key terms in the regulations; and viewing research oversight as a system with important roles for researchers, IRBs and their research institutions, sponsors and regulators of research, and the community.

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